Today is a significant day, as today, May 26 2021, is the date of applicability (DoA) of the European Medical Device Regulation (MDR, also known as 2017/745). While that is a major milestone, I doubt whether champaign corks were heard popping at medical device companies, Notified Bodies, or the European Commission. It has been a rocky road so far, and one can foresee more bumps in the journey ahead until the end of the ‘grace period’, which is set to end May 26, 2024.
Challenges ahead for the European medical devices sector
Eudamed still missing in action
Eudamed was supposed to be ready at the original Date of Applicability of the MDR, but in 2019, the European Commission announced a delay in the introduction of 2 years. Fast-forward to 2021, and currently there is only 1 module (Actor registration, which went live in December 2020) of the envisioned 6 that is ready for use. I haven’t seen any announcements on when the complete system will be available, but the next two modules (UDI/device registration and registration of certificates and Notified Bodies) are set to be ready in September of this year, according to the Commission. No date has been communicated for the other three modules (covering clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance). While the use of Eudamed only becomes mandatory while the system is in production in its entirety, manufacturers would be adviced to start using the modules as they become available.
Notified Bodies
The situation of Notified Bodies has been a concern for years, and still remains a concern today. After issues with European regulatory oversight of medical devices came to light around 2010 (mainly due to two widely publicized cases; one due to outright fraud that went undetected for nine years (the PIP scandal, were a French company (Poly Implant Prothèse) used industrial-grade silicone instead of the mandated medical-grade silicone, and the other one being Metal-on-Metal hip replacements which turned out to have unacceptably high failure rates, leading to a myriad of health issues in the recipients of these devices), the European Commission and the National Competent Authorities ramped up their scrutiny of Notified Bodies which led to many of them going out of business (by 2018, the number of Notified Bodies remaining designated for MDD conformity assessments was 50, down from the original 80).
As of today, there are still 50 Notified Bodies designated under the outgoing MDD, and more worryingly, only 20 Notified Bodies have been designated to perform conformity assessments under the new MDR. And while a near-term crisis seems to have been succesfully averted, it looks like a large bottleneck has been created further down to road, as the below image, taken from a recent Team-NB survey report, illustrates.
While it was already clear in September that a huge number of new MDR certifications would be required in 2024, the number of certificates expiring in 2024 increased by a whopping 37% in the last three months of 2020. While it may be the case that some manufacturers chose to recertify under the outgoing directive because they failed to prepare for the MDR in a timely manner, this state of affairs is mostly due to the COVID-19 pandemic and the fact that MDD certifications were allowed to proceed remotely, whereas sadly, MDR certification audits were not. While the number of FTE’s employed at Notiofied Bodies has grown by more than threefold (from 1080 to 3448, including external contractors), which far outgrows the increase in the number of certificates which stand at 35% during the same period, it will be interesting to see how Notified Bodies will cope with this future workload.
As Team NB writes:
The increase in number of employees is small in comparison with the wishes of notified bodies to hire personnel. The difference is mainly related to the difficulties to find people with the required competence on the market. Notified Bodies are facing stiff competition with manufacturers and consulting companies to hire people with previous work experience in medical devices.
What else?
Apart from what I wrote above about EUDAMED, two key parts that still have to be established are harmonized device standards and Common Specifications for devices without a medical purpose. According to the EC implementation rolling plan, last updated in April, both are due for the third quarter of this year.